US5129894A - Package units for medical purposes - Google Patents

Package units for medical purposes Download PDF

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Publication number
US5129894A
US5129894A US07/229,012 US22901288A US5129894A US 5129894 A US5129894 A US 5129894A US 22901288 A US22901288 A US 22901288A US 5129894 A US5129894 A US 5129894A
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Prior art keywords
container
sheet
polyamide
package unit
laminate
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US07/229,012
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Inventor
Klaus Sommermeyer
Jurgen Koenig
Franz Cech
Reinhold Herbert
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Fresenius SE and Co KGaA
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Fresenius SE and Co KGaA
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Assigned to FRESENIUS AG reassignment FRESENIUS AG ASSIGNMENT OF ASSIGNORS INTEREST. Assignors: CECH, FRANZ, HERBERT, REINHOLD, KONIG, JURGEN, SOMMERMEYER, KLAUS
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/34—Layered products comprising a layer of synthetic resin comprising polyamides
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/08—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B7/00—Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
    • B32B7/04—Interconnection of layers
    • B32B7/12—Interconnection of layers using interposed adhesives or interposed materials with bonding properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2375/00—Polyureas; Polyurethanes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2377/00—Polyamides
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00—Containers; Receptacles
    • B32B2439/80—Medical packaging

Definitions

  • the subject of the present invention is package units for medical purposes, in particular for receiving and/or storing sterilizable preparations for parenteral use of dialysis solutions, including a container having at least one discharge spout and consisting of a polymeric material including polyamide, which possibly have also an inner container or an outer container, and method for the production thereof.
  • thermoplastic polymeric material that the latter be stable at least up to the heating temperature.
  • a storage bag must be easy to make in economical manner in an automatic production process and disposable after use because of its low value. It should also be flexible, foldable and in the processed state transparent so that changes of the liquid contained in the bag can be immediately noticed.
  • plasticizers for example diisoctylphthalate
  • plasticizers of softeners are not completely enclosed in the voids between the polymeric chains and can therefore be dissolved out of the polymer by the water or aqueous solution introduced into the bag so that contamination of the liquid contained in the bag occurs.
  • Estimates have shown that a patent treated for a relatively long time using such PVC bags will have absorbed a few g plasticizer and this in itself is extremely worrying physiologically and can lead to permanent damage in the patient.
  • such a bag consisting of soft PVC easily be attacked by microorganisms which in particular dissolve out the plasticizers and thus regularly destroy the bag. To prevent this, after filling such a PVC bag had to be protected from harmful organisms by a special surrounding package.
  • CH-PS 444,382 describes such a plastic bag which can be used for therapeutical solutions to be employed parenterally.
  • the wall consists of a plastic laminate which comprises on the outside, i.e. the side remote from the liquid, a PVC layer and on the inside a polyhalogen hydrogen synthetic resin layer.
  • the latter layer does not have any pharmacologically inadmissible constituents which by dissolving might pass into the solution contained in the bag.
  • the polyhalogen hydrocarbon substances employed have the disadvantage that they are very expensive to produce and process and do not fuse adequately at the welds so that there is still a direct contact with the PVC. This contact also exists moreover at the discharge opening which is usually completely made of PVC and with which further PVC compound flexible tubes can be connected.
  • these plastic bags represent an environmental hazard because burning of said bags leads to highly aggressive hydrocarbons.
  • Polyolefins e.g. polyethylene
  • Polyolefins are free from plasticizer and are thus not attacked by microorganisms. In addition, they have a good water vapour barrier and are sterilizable. Bags of polyolefins are described for example in DE-PS 3,200,264 and DE-PS 3,305,365.
  • Such a coating is also used for safety reasons because even on extremely careful production the bag sheet can have pinholes which cannot be seen and which can impair the sterility of the solution introduced.
  • a covering or coating can also considerably improve the mechanical loadability of such a bag so that such a bag even when dropped from a height of several metres does not burst.
  • the sheet or layer used is one having a higher melting point than the polymer facing the solution, i.e. which at the melting temperature of the inner sheet does not itself melt and consequently will not stick to a sealing tool either.
  • Such an outer sheet can thus also serve as parting agent in the sealing of the inner sheet.
  • polymers for coating the polyolefin sheet are polymers having a low water vapour permeability and a low oxygen permeability, such as polyamides, and as polyamide polycaprolactam (PA 6) is preferred, containing no stabilizing additives and thus complying in its composition with the requirements for use in the foodstuff sector.
  • polyamides such as polyamides
  • PA 6 polyamide polycaprolactam
  • Bags of such laminates are therefore extremely dubious from the medical point of view.
  • the problem underlying the present invention is to provide package units of the aforementioned type which do not have the disadvantages of the known package units or bags, are unobjectionable from the medical point of view and in which no migration of foreign constituents into the solution to be stored takes place, and which furthermore are mechanically stable, transparent and heat-sterilizable and have low water vapour permeability and low oxygen permeability and in addition cannot be attacked by microorganisms.
  • polymeric material including polyamide herein polyamide or polyamide-containing laminate of polymeric material is meant.
  • the container of the package unit according to the invention may consist both only of polyamide 66 and of a laminate of polymeric material including polyamide 66.
  • Polyamide 66 means the polycondensate obtained by polycondensation of hexamethylene diamine and adipic acid.
  • polyamide 66 in contrast to the other polyamides, for example polyamide 6, polyamide 11, polyamide 12 or polyamide 13, as polymeric material for the container for the package unit after the sterilization no foreign constituents or no ponderable amounts of foreign constituents are to be found in the liquid to be stored.
  • polyamide 66 is employed in the laminate with polyolefin sheets, the polyolefin sheet being disposed on the side facing the liquid to be stored and on the outside the sheet of polyamide 66, the two sheets being bonded together in usual manner by means of an adhesive.
  • the polyamide 66 is used in a laminate with a polyolefin, the polyolefin sheet being disposed on the side facing the liquid to be stored and the polyamide 66 sheet on the outside and the two sheets being bonded together in usual manner by means of an adhesive.
  • polymers of olefins are suitable, such as ethylene, propylene, butylene and the like, which are possibly substituted.
  • substituents for example the methyl or ethyl group, the vinyl group and halogen atoms, in particular fluorene or chlorine atoms may be present.
  • ethylene and propylene in particular ethylene polymerized to polyethylene being employed.
  • polyolefins are: polyethylene, polypropylene, poly-n-butylene, polyisobutylene, poly-4-methylpentene-1, chlorosulfonated polyethylene, polystyrene, halogenated polyethylene, such as polyvinyl fluoride, polyvinylidene fluoride and polyvinylidene chloride, polymethylmethacrylate and the like.
  • the olefins employed for making the above polyolefins may also be used as copolymers and mixed polymers with other vinyl compounds, for example ethylene/propylene plastics, poly (ethylene/vinyl acetate), acrylonitrile/butadiene/styrene polymers, ethylene-propylene block copolymers, styrene copolymers, copolymers containing vinylidene fluoride and copolymers containing styrene.
  • ethylene/propylene plastics poly (ethylene/vinyl acetate), acrylonitrile/butadiene/styrene polymers, ethylene-propylene block copolymers, styrene copolymers, copolymers containing vinylidene fluoride and copolymers containing styrene.
  • polyolefins are products which are made by the vinyl polymerization of possibly substituted olefin, preferably ethylene. These products may also have slight additives of other polymers which do not essentially destroy or change the structure of said polyolefins. Thus, for example, small amounts of styrene-substituted or polyacrylonitrile-substituted ethylene compounds may be added. The resulting polyolefin products are considered as belonging to the polyolefins specified above.
  • polyethylene is used as material for the inner sheet, possibly with slight additions of vinyl acetate in the form of the copolymer of ethylene and vinyl acetate.
  • the vinyl acetate content may be up to 10% by weight.
  • a polyethylene is used of medium or high density (MDPE and HDPE) which is usually made by low-pressure polymerization.
  • MDPE and HDPE medium or high density
  • the density lies within a range of 0.91 to 0.94 g/cm 3 , in particular about 0.935 g/cm 3 .
  • the polyethylene preferably used according to the invention has a high molecular weight and a narrow molecular weight distribution.
  • polyolefins do not have a melting point below the sterilization temperature of about 110°-120° C.
  • the melting range should be above 110° C.
  • the sheets suitable for the laminates the usual extruding method of making sheets or hose sheets can be employed and do not present the expert with any appreciable problems.
  • the polymeric inner sheet and the polymeric outer sheet are bonded together in a manner known per se. Any known method suitable for making the laminates according to the invention can be employed.
  • the inner and outer sheets are adhered together by means of a laminating adhesive such as polyvinylidene chloride or a polyurethane.
  • a polyurethane adhesive can advantageously be a two-component adhesive, the first component consisting of a laminated adhesive and the second component of an additive lacquer.
  • the polyolefin used as inner sheet can be extruded in the form of a hose-like sheet and thereafter adhered to the laminated sheet of polyamide 66 using the laminating adhesive mentioned above, polyurethane being preferred.
  • FIG. 1 is a side view in cross-section of a polymeric laminate material according to the present invention.
  • FIG. 2 is a partial side view in cross-section of a package unit according to the present invention.
  • FIG. 3 is a partial side view in cross-section of a package unit according to the present invention.
  • Preferred laminates have at a temperature of about 23° C. and a relative air humidity of 85% as a rule a water vapour permeability according to DIN 53122 of ⁇ 1.
  • Such values apply to standard laminates which are advantageously up to 0.2 mm thick, with a thickness of 50 to 150 ⁇ m, in particular about 100 ⁇ m, for the polyolefin sheet and 20 to 100 ⁇ m, in particular 30 to 80 ⁇ m, for the polymeric laminating sheet of polyamide 66.
  • a particularly suitable laminate consists of a 130 ⁇ m thick polyethylene sheet and a 50 ⁇ m thick sheet of polyamide 66.
  • the oxygen permeability is reduced, this value lying below 15 cm 3 /m 2 ⁇ day ⁇ bar pressure difference.
  • the sheets used according to the invention for making the laminate have been approved both by the Federal Health Office in Berlin and by the FDA (Federal Drug Administration) in the U.S.A. as physiologically harmless for use in the foodstuff sector and in the medical sector.
  • the laminates of polyolefin and polyamide 66 used for the package units according to the invention are free from plasticizers and additives or constituents which might possibly be physiologically objectionable and in particular could diffuse or migrate into the aqueous solution.
  • the laminates used according to the invention are heat-sterilizable, clear and transparent and also have these properties after the sterilization.
  • the package units according to the invention or the containers of said package units according to the invention may have any suitable shape or form. Expediently, they are made in the form of bags.
  • the package units or containers or bags according to the invention have at least one discharge spout or outlet nozzle which is formed in hose manner or includes a tube piece or insert piece.
  • the latter may consist of respectively suitable material and can be formed in any desired manner and secured in the container or bag. For example, they may be formed in the manner described in DE-PS 3,305,365 and DE-PS 3,200,264, to which reference is made hereby, and consist of the materials specified therein.
  • the containers may be made by an extrusion of hose-like sheets, corresponding cutting to size of the sheets and lamination and subsequent edge welding thereof.
  • the containers, in which the edge provided for the discharge spout remains unwelded, are subsequently fused to a tube piece possibly comprising a bonding layer or an insert piece comprising the discharge opening(s) and possibly surrounded by a bonding layer.
  • the tube or insert piece is provided with such a bonding layer in accordance with the usual techniques, as can be done for example by simply drawing on or pushing over the elastic material of the bonding layer in hose form onto the tube piece or insert piece and introducing it into the opened container. Thereafter the heat sealing of the entire still not welded edge to the hose connection piece or to the tube piece or insert piece provided with the bonding layer is carried out. If several tube pieces are provided this processing step is carried out simultaneously, corresponding sealing tools being of course employed. The heat sealing is carried out by the usual methods.
  • the sterilization of the containers thus made is by the usual methods in an autoclave and of course to avoid bursting of the containers in the autoclave an excess pressure must be applied to balance the pressure obtaining in the container interior.
  • an excess pressure must be applied to balance the pressure obtaining in the container interior.
  • the excess of this pressure over the pressure obtaining in the container is not critical but for example it should be at least 0.5 bar greater than the pressure obtaining in the container. It may be 2 to 3 bar, for example 2.2 bar.
  • the laminates according to the invention can further be subjected to a crosslinking after the sealing of the containers, before the liquid to be stored is introduced and before the sterilization.
  • the container of the package unit according to the invention may be surrounded by a further container, an outer container.
  • Suitable materials for such a further container or outer container are materials which are able to protect the container according to the invention, which when using an outer container represents the inner container, from mechanical damage, avoid any water vapour losses, prevent access of microorganisms (no fungus formation or sporulation), represent a gas barrier, i.e. oxygen barrier, are preferably substantially transparent and permit a long-time storage of the package units.
  • Examples of such materials are metal or plastic foils or laminates which fulfil the aforementioned conditions.
  • Preferred are foils or laminates of plastic.
  • metal foils or laminates are:
  • Suitable as plastics are essentially the polyolefins as names above in conjunction with the containers according to the invention, which when using outer containers represent the inner containers.
  • Said plastics may be used in the form of individual sheets or in the form of laminates of two or more sheets. Preferred are laminates of two sheets: inner sheet, i.e. the sheet facing the inner container, and outer sheet, i.e. the outer foil or sheet coming into contact with the environment.
  • Particularly suitable according to the invention for the outer container are laminates of polyolefins as named above for the inner container, polyethylene being particularly preferred as polyolefin, and polyesters, copolymers of ethylene and vinyl alcohol, copolymers of ethylene and vinyl acetate.
  • suitable laminates are laminates of polyethylene sheet and polyester sheet, as polyester polyethylene terephthalate and polybutylene terephthalate being particularly suitable, laminates of polyethylene sheet and a sheet of copolymers of ethylene and vinyl alcohol, laminates of polyethylene sheet and a sheet of copolymers of ethylene and vinyl acetate.
  • this outer container further provides a double oxygen barrier and the container contents, i.e. the liquid or solution to be stored, are protected from oxidation.
  • the inner container is made as described above; when using a laminate of a polyamide 66 sheet and a polyolefin sheet the polyolefin sheet is arranged on the side facing the liquid to be stored and the sheet of polyamide 66 is arranged on the outer side and the two sheets are bonded together by means of an adhesive. Thereafter the inner container thus made, possibly after crosslinking, is filled with the liquid or solution to be stored, sealed and sterilized as described above. After cooling and drying of said sterilized inner container the sealed and sterilized inner container filled with the liquid to be stored is provided in a manner known per se with the outer container.
  • the sterlized dried and cooled inner container is placed in a lower web deep-drawn corresponding exactly to its contours for the outer container and covered with the upper web for the outer container. Thereafter, a vacuum is applied to the outer container, which should be about 900 to 900 mbar. At the same time or directly thereafter the edges of the upper web and lower web of the outer container are welded together. When the vacuum is applied the sheet of the outer container bears sealingly on the laminate of the inner container.
  • the lower web and the upper web may consist of the same or different material and consist preferably of the same material.
  • the upper web and the lower web of the outer container may have the same or different thicknesses and are preferably of the same thickness. It is important for the materials of the lower web and upper web to be weldable together, in the case of laminates the inner layers of the lower web and upper web. If the lower web is deep-drawn said lower web should be preferably somewhat thicker than the upper web.
  • the upper web and the lower web have expediently thicknesses of 100 to 200 ⁇ m.
  • the container referred to above and consisting of polyamide 66 or a polymeric laminate including polyamide 66 may represent the outer container and surround an inner container of polymeric material having at least one discharge spout; when using a laminate including polyamide 66 for the outer container the side of the laminate facing the inner container consists of polyolefin sheet and the outer side of the laminate of polyamide 66 sheet and the two sheets are bonded together in the usual manner by means of an adhesive.
  • any polymeric material may be used which is suitable for storing and keeping the sterilizable preparations for parenteral use or the dialysis solutions, permits sterilization and has no migratable substances.
  • the container material may be in the form of individual sheets or in the form of laminates and is preferably substantially transparent. Examples of such materials are: polyolefins, polyesters and copolymers thereof.
  • the polyolefins include the polyolefins mentioned above, including PVC and soft PVC, polyethylene being preferred.
  • polyester polyethylene terephthalate is for example suitable.
  • Particularly preferred as material for the inner containers according to this embodiment, in the form of individual sheets or laminates, are polyethylene, copolymers of ethylene and propylene and polyester, such as polyethylene terephthalate.
  • Suitable laminates are composite sheets of the aforementioned materials, possibly with embedded ethylene/vinyl alcohol (EVAL) barrier layers.
  • suitable laminates are laminates of polyolefin sheets, in particular polyethylene, laminates of polyethylene sheet and polyester sheet, polyethylene terephthalate being particularly suitable as polyester, laminates of polyethylene sheet and sheet of copolymers of ethylene and vinyl alcohol, laminates of polyethylene sheet and sheet of copolymers of ethylene and vinyl acetate.
  • the production of the package units according to this embodiment is carried out in that firstly the inner container with at least one discharge spout, as described above, is made from the materials specified above and then, possibly after any necessary crosslinking, filled with the liquid or solution to be stored and subsequently sealed. Thereafter the inner container filled with liquid and sealed is provided with the outer container of polyamide 66 or a polymeric laminate including polyamide 66, when using a laminate including polyamide 66 for the outer container the side of the laminate facing the inner container consists of polyolefin sheet and the outer side of the laminate consists of polyamide 66 sheet, and the two sheets are bonded together in the usual manner by means of an adhesive and thereafter subjected to the sterilization as described above.
  • the method is carried out in such a manner that the sealed inner container filled with the liquid or solution to be stored is placed in a deep-drawn lower web for the outer container corresponding exactly to its contours and covered with the upper web for the outer container and thereafter a vacuum which should be about 900 to 980 mbar is applied to the outer container. Simultaneously or directly thereafter the edges of the upper web and lower web of the outer container are welded together. When the vacuum is applied the sheet or laminate of the outer container comes to lie sealingly on the inner container.
  • the lower web and the upper web of the outer container may consist of the same or different material and consist preferably of the same material.
  • the upper web and the lower web of the outer container may have the same or different thickness and are preferably of equal thickness.
  • the materials of the lower web and upper web in the case of laminates the inner layers of the lower web and upper web, are weldable together. If only the web is deep-drawn said lower web should preferably be somewhat thicker than the upper web.
  • the upper and lower web expediently have thicknesses of 100-200 ⁇ m.
  • the package unit thus made filled with the liquid or solution to be stored and sealed and comprising the inner and outer containers is thereafter sterilized in a pressure autoclave at a temperature of about 120° C. and an excess pressure of about 2.2 bar.
  • a polymeric laminate material 10 has a sheet A of polyamide 66 which is bonded to a sheet B of polyolefin by an adhesive layer C.
  • FIG. 2 partially illustrates a package unit 12 according to the present invention which has a first inner container 14 made from a polymeric laminate 10 (as in FIG. 1) disposed in a second container 16 made from a sheet D, preferably a metal or plastic foil or a polymeric laminate.
  • a sheet D preferably a metal or plastic foil or a polymeric laminate.
  • the sheet D bears sealingly against, but is not bonded to, the sheet A.
  • FIG. 3 partially illustrates a package unit 20 according to the present invention which has a first container 22 made from a polymeric laminate 10 in which is disposed a second container 24 made from a sheet E, preferably a polymeric material.
  • the sheet B lies on, but is not bonded to, the sheet E.
  • the polyethylene sheet represents the inner sheet and the sheet of polyamide 66 the outer sheet.
  • the bag thus made was filled with infusion solution, sealed and introduced into a pressure autoclave where it was sterilized at a temperature of about 120° C. and an excess pressure of about 2.2 bar.
  • the laminate had a thickness of 180 ⁇ m, the polyethylene sheet being 130 ⁇ m thick and the polyamide 66 sheet 50 ⁇ m thick.
  • the storage bag thus made is transparent.
  • an inner bag having a capacity of about 1 l was made from polyethylene sheet (thickness 130 ⁇ m), the sheet edge welded except for the discharge openings and a tube piece of polycarbonate comprising a bonding layer of a copolymer of ethylene and vinyl acetate with a vinyl acetate content of 28% was introduced into the discharge opening and secured by means of heat sealing.
  • the bag (inner bag) made in this manner was filled with infusion solution, sealed and, without previous sterilization, placed on a deep-drawn lower web of an outer bag or surrounding bag with contours exactly corresponding to those of the inner bag and covered with the upper web. Thereafter a vacuum of 950 mbar was applied to the outer or surrounding bag as subsequently the lower web and the upper web of the outer or surrounding bag were welded together along the edges.
  • the upper web and the lower web of the outer or surrounding bag each consisted of a laminate of polyethylene sheet and a sheet of polyamide 66 as was used for making the bag according to Example 1.
  • the sheet of the laminate of the outer bag facing the inner bag consisted of polyethylene and the outer sheet of the laminate of the outer bag consisted of polyamide 66.
  • the laminate for the lower web had a thickness of 1.25 ⁇ m, the ethylene sheet having a thickness of 75 ⁇ m and the sheet of polyamide 66 a thickness of 50 ⁇ m.
  • the thickness of the laminate of the upper web was 1.25 ⁇ m, the polyethylene sheet having a thickness of 75 ⁇ m and the sheet of polyamide 66 a thickness of 50 ⁇ m.
  • the package unit made in this manner, filled with infusion solution and sealed and comprising an inner and outer bag was subsequently introduced into a pressure autoclave and there sterilized at a temperature of about 120° C. and an excess pressure of about 2.2 bar.
  • the package unit obtained and comprising the outer or surrounding bag of a laminate of polyethylene sheet and a sheet of polyamide 66 was transparent and even after sterilization and long storage permitted excellent visual inspection for the infusion solution contained in the bag.
  • the infusion solution surrounded by the inner bag and the outer bag even after sterilization no foreign constituents were detected in ponderable amounts (weighing accuracy ⁇ 1 mg).
  • the stored infusion solution remained clear. No migration of foreign constituents occurred and no oxidation products or any other microorganisms (fungus formation or sporulation) of any kind were found.
US07/229,012 1987-08-06 1988-08-05 Package units for medical purposes Expired - Lifetime US5129894A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19873726064 DE3726064A1 (de) 1987-08-06 1987-08-06 Verpackungseinheit fuer medizinische zwecke
CA000574808A CA1332051C (fr) 1987-08-06 1988-08-15 Conditionnements unitaires pour usage medicinal

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US5129894A true US5129894A (en) 1992-07-14

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US07/229,012 Expired - Lifetime US5129894A (en) 1987-08-06 1988-08-05 Package units for medical purposes

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US (1) US5129894A (fr)
EP (1) EP0302357B2 (fr)
JP (1) JPH021278A (fr)
AT (1) ATE88885T1 (fr)
CA (1) CA1332051C (fr)
DE (2) DE3726064A1 (fr)
DK (1) DK175811B1 (fr)
ES (1) ES2039519T5 (fr)
FI (1) FI102246B1 (fr)
NO (1) NO883466L (fr)

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US5686527A (en) 1993-11-16 1997-11-11 Baxter International Inc. Polymeric compositions for medical packaging and devices
US5706937A (en) * 1995-04-11 1998-01-13 Nissho Corporation Flexible dual-chambered container
US5772651A (en) * 1994-01-18 1998-06-30 Dibra S.P.A. Container for diagnostic contrast compositions
US5786598A (en) * 1996-05-22 1998-07-28 Purepulse Technologies, Inc. Sterilization of packages and their contents using high-intensity, short-duration pulses of incoherent, polychromatic light in a broad spectrum
US5925885A (en) * 1996-05-22 1999-07-20 Purepulse Technologies, Inc. Parametric control in pulsed light sterilization of packages and their contents
US5935847A (en) 1994-10-28 1999-08-10 Baxter International Inc. Multilayer gas-permeable container for the culture of adherent and non-adherent cells
US5941866A (en) * 1997-07-25 1999-08-24 Bracco Research Usa Means to maintain configuration of flexible medical container
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US6566659B1 (en) 1996-02-15 2003-05-20 Purepulse Technologies, Inc. Parametric control in pulsed light sterilization
US7793655B2 (en) 1996-04-19 2010-09-14 Boehringer Ingelheim Pharma Gmbh & Co. Kg Two-chamber cartridge for propellant-free metering aerosols
US7213593B2 (en) 1996-04-19 2007-05-08 Boehringer Ingelheim Kg Two-chamber cartridge for propellant-free metering aerosols
US7980243B2 (en) 1996-04-19 2011-07-19 Boehringer Ingelheim Pharma Gmbh & Co., Kg Two-chamber cartridge for propellant-free metering aerosols
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US20030155531A1 (en) * 1996-05-22 2003-08-21 Clark Reginald Wayne Sterilization of packages and their contents using light
US6433344B1 (en) 1996-05-22 2002-08-13 Purepulse Technologies, Inc. Pulsed light sterilization of drinking water and drinking water containers
US5925885A (en) * 1996-05-22 1999-07-20 Purepulse Technologies, Inc. Parametric control in pulsed light sterilization of packages and their contents
US5786598A (en) * 1996-05-22 1998-07-28 Purepulse Technologies, Inc. Sterilization of packages and their contents using high-intensity, short-duration pulses of incoherent, polychromatic light in a broad spectrum
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US6528173B1 (en) 1997-02-24 2003-03-04 Baxter International Inc. Coextruded multilayer films for sterilizable fluid containers
US5941866A (en) * 1997-07-25 1999-08-24 Bracco Research Usa Means to maintain configuration of flexible medical container
US6361843B1 (en) 1997-09-22 2002-03-26 Baxter International Inc. Multilayered polymer structure for medical products
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US5989237A (en) 1997-12-04 1999-11-23 Baxter International Inc. Sliding reconstitution device with seal
US6063068A (en) 1997-12-04 2000-05-16 Baxter International Inc. Vial connecting device for a sliding reconstitution device with seal
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US6019750A (en) 1997-12-04 2000-02-01 Baxter International Inc. Sliding reconstitution device with seal
US6090092A (en) 1997-12-04 2000-07-18 Baxter International Inc. Sliding reconstitution device with seal
US6071270A (en) 1997-12-04 2000-06-06 Baxter International Inc. Sliding reconstitution device with seal
US6183460B1 (en) 1998-01-22 2001-02-06 Baxter International Inc. Multi-use solution container having flaps
US20040143235A1 (en) * 1998-02-27 2004-07-22 Boehringer Ingelheim Gmbh Container for a medicinal liquid
US7963955B2 (en) 1998-02-27 2011-06-21 Boehringer Ingelheim International Gmbh Container for a medicinal liquid
US6685691B1 (en) * 1998-02-27 2004-02-03 Boehringer Ingelheim Gmbh Container for a medicinal liquid
US6113583A (en) 1998-09-15 2000-09-05 Baxter International Inc. Vial connecting device for a sliding reconstitution device for a diluent container
US8226627B2 (en) 1998-09-15 2012-07-24 Baxter International Inc. Reconstitution assembly, locking device and method for a diluent container
US6582415B1 (en) 1998-09-15 2003-06-24 Thomas A. Fowles Sliding reconstitution device for a diluent container
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US7802568B2 (en) 1999-02-23 2010-09-28 Boehringer Ingelheim International Gmbh Cartridge for a liquid
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US20020197478A1 (en) * 1999-03-01 2002-12-26 Muggli Olivier Y. Package for medical device
US10322224B2 (en) 2000-02-10 2019-06-18 Baxter International Inc. Apparatus and method for monitoring and controlling a peritoneal dialysis therapy
US9474842B2 (en) 2000-02-10 2016-10-25 Baxter International Inc. Method and apparatus for monitoring and controlling peritoneal dialysis therapy
US8323231B2 (en) 2000-02-10 2012-12-04 Baxter International, Inc. Method and apparatus for monitoring and controlling peritoneal dialysis therapy
US6969483B1 (en) 2000-03-16 2005-11-29 Baxter International Inc. Autoclavable, non-adherent, heat sealable polymer blends for fabricating monolayer and multiple layered films
US7267885B1 (en) 2000-03-16 2007-09-11 Baxter International Inc. Containers and peelable seal containers of new non-PVC material
US6743523B1 (en) 2000-03-16 2004-06-01 Baxter International Inc. Multiple layer film of a new non-PVC material
US6372848B1 (en) 2000-10-10 2002-04-16 Baxter International Inc. Blend of ethylene and α-olefin copolymers obtained using a metallocene catalyst for fabricating medical films and tubings
WO2004039582A1 (fr) * 2001-10-19 2004-05-13 Baxter International Inc. Structure polymere multicouche
US8545435B2 (en) 2002-01-03 2013-10-01 Baxter International, Inc. Method and apparatus for providing medical treatment therapy based on calculated demand
US7025754B2 (en) * 2002-07-01 2006-04-11 Ventaira Pharmaceuticals, Inc. Drug containment system
US20040001655A1 (en) * 2002-07-01 2004-01-01 Proicou George C. Drug containment system
US8206338B2 (en) 2002-12-31 2012-06-26 Baxter International Inc. Pumping systems for cassette-based dialysis
US7744554B2 (en) 2002-12-31 2010-06-29 Baxter International Inc. Cassette alignment and integrity testing for dialysis systems
AU2004275764B2 (en) * 2003-09-22 2010-01-14 Baxter Healthcare S.A. High-pressure sterilization to terminally sterilize pharmaceutical preparations and medical products
US8022375B2 (en) 2003-12-23 2011-09-20 Baxter International Inc. Method and apparatus for validation of sterilization
US20090118694A1 (en) * 2006-03-10 2009-05-07 Takeshi Inuzuka Fluid-supplement bag package and protective bag
US7998115B2 (en) 2007-02-15 2011-08-16 Baxter International Inc. Dialysis system having optical flowrate detection
US8361023B2 (en) 2007-02-15 2013-01-29 Baxter International Inc. Dialysis system with efficient battery back-up
US7731689B2 (en) 2007-02-15 2010-06-08 Baxter International Inc. Dialysis system having inductive heating
US8558964B2 (en) 2007-02-15 2013-10-15 Baxter International Inc. Dialysis system having display with electromagnetic compliance (“EMC”) seal
US8870812B2 (en) 2007-02-15 2014-10-28 Baxter International Inc. Dialysis system having video display with ambient light adjustment
US9799274B2 (en) 2007-02-15 2017-10-24 Baxter International Inc. Method of controlling medical fluid therapy machine brightness
US20100247935A1 (en) * 2009-03-24 2010-09-30 Baxter International Inc. Non-pvc films having barrier layer
US11179516B2 (en) 2017-06-22 2021-11-23 Baxter International Inc. Systems and methods for incorporating patient pressure into medical fluid delivery

Also Published As

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DE3726064A1 (de) 1989-02-16
ES2039519T3 (es) 1993-10-01
NO883466D0 (no) 1988-08-04
DK438188D0 (da) 1988-08-05
EP0302357B2 (fr) 1995-10-18
DK438188A (da) 1989-04-11
ATE88885T1 (de) 1993-05-15
DE3880756D1 (de) 1993-06-09
FI883639A0 (fi) 1988-08-03
CA1332051C (fr) 1994-09-20
FI102246B (fi) 1998-11-13
ES2039519T5 (es) 1996-01-01
FI883639A (fi) 1989-02-07
DE3726064C2 (fr) 1989-05-24
JPH021278A (ja) 1990-01-05
FI102246B1 (fi) 1998-11-13
EP0302357A2 (fr) 1989-02-08
DK175811B1 (da) 2005-03-07
EP0302357A3 (en) 1990-06-27
EP0302357B1 (fr) 1993-05-05
NO883466L (no) 1989-02-07

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